Sr Specialist, Quality, Standards and Compliance

The QSC Senior Specialist, under Global Safety Operations (GSO), within GPSRM, will support the monitoring of pharmacovigilance (PV) activities to ensure adherence to regulatory requirements, industry standards, company policies, and global regulations. The QSC Specialist is expected to appropriately perform all (PV) quality and compliance related activities with appropriate oversight.

Key Responsibilities

• Ensure adherence to PV quality and compliance standards by applying expertise in relevant processes and regulations, while leveraging a foundational understanding of related disciplines such as regulatory affairs, clinical safety to support cross-functional collaboration.
• Monitor and manage PV related quality events including deviations, CAPAs and effectiveness checks.
• Support the review and monitoring of PV compliance through various reports and oversight activities.
• Create and/or utilize tools (e.g. trackers, checklists, etc.) to systematically monitor and assess compliance with regulatory requirements and internal standards.
• Contributes to the conduct and oversight of post-marketing activities/studies including but not limited to, post-market non-interventional studies, post-authorization safety studies, investigator-initiated trials, patient support programs, market research, etc.
• Collaborate with cross-functional teams, such as Regulatory Affairs, Quality Assurance, Medical Affairs, and IT, to address quality and compliance-related issues and drive continuous improvement initiatives.
• Support the maintenance of the global and local Pharmacovigilance System Master File (PSMF).
• Participating in the development, review and compliance evaluations of GPSRM procedures.
• Prepare pharmacovigilance reports, presentations, and documentation for management reviews and health authority inspections/audits.
• Support PV audit and regulatory inspection preparation.
• Undertake other activities as needed or as requested by the supervisor.

Qualifications

• Education: Bachelor's degree in life sciences or related field.
• Experience: Minimum of 3 years in the pharmaceutical or life sciences industry with a focus on PV operations, quality, and compliance in a global environment. Strong knowledge pharmacovigilance requirements, including but not limited to relevant FDA, EMA, International Conference on Harmonisation (ICH) guidelines and Good Vigilance Practices (GVP) guidelines.
• Solid skills and experience in:
  • Demonstrates understanding of the principles and application of quality and regulatory compliance
  • Demonstrates ability to effectively communicate and influence the outcomes of the decision-making process
  • Maintains a contemporary knowledge of current industry trends, standards and methodologies as it relates to PV quality management.
  • May conduct presentations on PV compliance and quality issues, initiatives and projects at cross functional meetings
• Supervision: Position will report directly to (Associate) Director, Global Patient Safety & Risk Management. This individual is expected to work under direction of management and colleagues in Global Patient Safety & Risk Management.

About Alnylam:Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation of RNA interference (RNAi) into a whole new class of innovative medicines with the potential to transform the lives of people afflicted with rare and more prevalent diseases. Based on Nobel Prize-winning science, RNAi therapeutics represent a powerful, clinically validated approach to treating diseases at their genetic source by "interfering" with mRNA that cause or contribute to disease. Since our founding in 2002, Alnylam has led the RNAi Revolution and continues to turn scientific possibility into reality.

Our culture:Our people-first culture is guided by our core values: fiercely innovative, open culture, purposeful urgency, passion for excellence, and commitment to people, and these values influence how we work and the business decisions we make. Thanks to feedback from our employees over the years, we've been fortunate to be named a top employer around the world. Alnylam is extremely proud to have been recognized as the #1 Large Employer by Boston Globe Top Places to Work in 2023 for the third consecutive year, one of Science Magazine's Top Biopharma Employers, one of America's Most Responsible Companies for 2024 by Newsweek, a Fast Company Best Workplace for Innovators, and a Great Place to Work in Canada, France, Italy, Spain, Switzerland, and UK - among others.

At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity. We are dedicated to building an environment where employees can feel that they belong, can bring their authentic selves to work, and achieve to their full potential. By empowering employees to embrace their unique differences at work, our business grows stronger with advanced and original thinking, allowing us to bring groundbreaking medicines to patients. Qualified applicants will receive consideration for employment without regard to their race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, ethnicity, marital status, protected veteran status, disability, or any other characteristics prohibited by law.